Letter to file vs Special 510 for additional accessory in orthopaedic kit

Registered

Our company has an orthopaedic kit that has recently been cleared by the FDA via Traditional 510k. We have a few more products in development that, once fully developed, we would like to add into the kit as accessories. The first we are looking to add is a battery powered driver specific to the size of our implants and current instruments.

Since the classification of such a device is exempt from a 510k, would it be necessary to complete a Special 510k to acknowledge the addition the the instruments, or would it suffice to just have a document on file that describes the rationale for not requiring a new 510k?

The guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device" mostly just refers to changes in the design of the original subject device of the 510k (in our case, the implants), but doesn't have reference to the addition of generic accessories to a kit.

Involved In Discussions

Is the driver designed specifically to work with the implant? If so, it is likely FDA would consider the driver to be the same class as the implant. FDA has a guidance on classification of accessories.